TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. All medical practitioners (doctors) who practice modern medicine will have to mandatorily register on the new National Medical Register established by the National Medical Commission.
Source: bit.ly/3YYlPoE

2. The Indian Government is reportedly considering to ban 34 multivitamin drugs.
Source: bit.ly/4e0490u

3. The Indian Government is planning to publish a new policy for promoting bio-technology sector called BioE3 (Biotechnology for Economy, Environment and Employment) Policy.
Source: bit.ly/3MiPNfw

4. A leading e-commerce giant has set up rest areas facility for its delivery partners in India. The rest area will have facilities like air conditioning, seating areas, drinking water, and mobile charging stations as a measure to provide them better working conditions.
Source: bit.ly/3MkPYHl

5. Amid rising cases of mpox globally, the World Health Organization (WHO) has reportedly relaxed the rules for its health partners to hold commercial discussions on mpox vaccines. It has also declared that partners like GAVI and UNICEF can begin purchasing mpox vaccines before WHO approves them.
Source:  bit.ly/3Z0RWV0

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s central food regulator, Food Safety and Standards Authority of India (FSSAI) has said that it is misleading to differentiate milk and milk products on whether they are made from A1 milk or A2 milk. All manufacturers and marketers and e-commerce entities have been directed to stop claims of A1 and A2 proteins present in the milk. All manufacturers have been given six months to exhaust all of the pre-printed labels containing claims about A1 and A2 proteins.
Source: bit.ly/4dz5awA

2. The Central Pollution Control Board (CPCB) has released updated guidelines for assessing environmental compensation to be levied on entities that violate the Plastic Waste Management Rules, 2016, including Extended Producer Responsibility (EPR) obligations.
Source: bit.ly/46Uh9lX

3. India’s Ministry of Health has banned the 156 fixed-dose combination (FDC) medications, commonly known as “cocktail drugs,” which include multivitamins, antibiotics, and painkillers. The ministry’s rationale is that these drugs have no there is no therapeutic justification and pose a risk to human health, even though there are safer alternatives available.
Source: bit.ly/3XfRVeq

4. The US Food and Drug Administration (FDA) has issued a draft guidance on pre-determined change control plans (PCCPs). The guidelines offer manufacturers a way to specify prospective modifications to a device and apply for premarket authorization for those changes in a marketing submission for the device. This eliminates the need for them to obtain FDA approval for each major change before it is implemented. The draft guidance is open to receiving comments from industry stakeholders till November 20, 2024.
Source: bit.ly/3AtTY5B

5. The Medicines and Healthcare products Regulatory Agency (MHRA), an agency of the Department of Health and Social Care in the United Kingdom, has ruled that a biopharmaceutical company has violated the country’s drug regulations by using a LinkedIn post to advertise prescription-only medicines to the general public.
Source: bit.ly/4fSmKgt

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s Environment Ministry has proposed to introduce extended producers responsibility for scrap of non-ferrous metals by way of amendment to Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2016.
Source: bit.ly/4fQHG7E

2. The deadline for declaration and registration of exotic animal species in possession of various individuals, organizations, zoos, etc is 28th August 2024. The registration of these exotic animal species is to be done in the PARIVESH 2.0 portal.
Source: bit.ly/3XaaXTA

3. India’s apex telecom regulator, the Telecom Regulatory Authority of India (“TRAI”) has issued directions to curb misuse of messaging services and protect consumers from fraudulent practices. TRAI has mandated that the messages containing URLs/ APKs/ OTT links/ Call back numbers, which are not whitelisted will not be sent with effect from 1st September 2024.
Source: bit.ly/3Xeorhb

4. A Texas Court has stayed the operation of ban on non-compete agreements stating that the Federal Trade Commission (FTC) lacks the authority to ban non-compete agreements which was supposed to go into effect 4th September 2024.
Source: bit.ly/3SYlZsy

5. The Supreme Court of India, while observing the working conditions of doctors and healthcare professionals and their susceptibility to violence, has constituted a ten (10) member task force to formulate a national framework (protocol) for ensuring their safety and facilities. The task force will submit its interim report within three (3) weeks and final report within two (2) months.
Source: bit.ly/4cHpv1C

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Drug Controller in Kerala has reportedly stated that there is no objection to display discount on flex board of retail drug stores. However, all retail drug stores are required to display a price list of medicines which will allow consumer to evaluate which drugs are available at a discount and make informed choices.
Source: bit.ly/4ctkgT3

2. As per India’s Central Food Regulator, the claim of 100% fruit juice on packaging of juices which are reconstituted from fruit concentrate, or which are not reconstituted but to which water has been added, is misleading and therefore prohibited. Any pre-printed packaging material which contains the misleading claim should be utilized by the Food Business Operators (FBOs) before 31st December 2024. Fruit juices manufactured before 31st December 2024 but which carry the misleading claim on the package will be permitted to be sold in the market until their expiry.
Source: bit.ly/4fV2gDN

3. A trademark infringement suit filed by a U.S. fast-food burger chain has been decided in favor of a Pune-based burger joint on the grounds of prior use and honest use in India.
Source: bit.ly/4dGZLmY

4. Indian medical gloves manufacturers have raised strong objection with Indian government about ongoing import of chlorinated gloves into India despite there being a ban on its use by healthcare facilities.
Source: bit.ly/3AyqQdG

5. 12% of all spices tested between May and July have reportedly failed to meet quality standards.
Source: bit.ly/3AwNV0b

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. A national association of medical professionals, the Indian Medical Association has declared a 24-hour nationwide withdrawal of non-emergency services from 6 a.m. on 17th August, 2024 to protest against the alleged rape and murder of a trainee doctor at the state-run hospital in Kolkata. Essential services will be continued, but outpatient departments and elective surgeries will be halted. The withdrawal will operate across all sectors wherever modern medicine doctors are providing services.
Source: https://bit.ly/3YYu5oC

2. Under the direction of the Union Health Ministry, the National Medical Commission (NMC) has advised all medical colleges and institutions to create a policy that will ensure that all staff members, including faculty, medical students, and resident physicians, have a safe place to work on campus. Adequate safety precautions in the OPD, wards, casualties, hostels, and other open spaces on campus and in the residential quarters should be guaranteed by the policy.
Source: bit.ly/3YTA0eY

3. The National Green Tribunal has set aside a pharmaceutical company’s environmental clearance to expand its facility on grounds that even though it has an effluent treatment plant, the absence of pharmaceutical waste in treated waste water cannot be ruled out. The said pharmaceutical company was going to let out treated waste water into the sea and this may harm neighbouring aqua farms and have an adverse effect on human health when such aquatic food is consumed.
Source: bit.ly/3SVOneF

4. India’s anti-trust regulator, the Competition Commission of India (CCI), has dismissed a complaint alleging cartelisation by 29 pharmaceutical companies to manipulate government tenders for procurement of medicines on grounds that the compliant was vague and did not disclose sufficient details.
Source: bit.ly/3SXLPgl

5. The US government has announced first set of price cuts to popular prescription drugs which are part of  the government’s Medicare programme. The revised prices of the drugs, which include widely used blood thinners and arthritis medications, will take effect from 2026.
Source: bit.ly/3AFf94I

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s Environment Ministry is planning to exempt white category industries i.e., low environment risk industries from the requirement to obtain consent before establishing and operating an Industry provided the industry makes a self-declaration to the concerned pollution control board.
Source: https://bit.ly/3LygA7t
Source: https://bit.ly/4d7nqNv

2. India’s environment ministry is planning to exempt industries who have already obtained Environmental Clearance (EC) from obtaining environmental consent to establish the industry.
Source: https://bit.ly/3LygA7t
Source: https://bit.ly/4d7nqNv

3. After Odisha and West Bengal, other states in India are reportedly considering to allow online sale and home delivery of alcoholic beverages.
Source: https://bit.ly/3WiXAyu

4. Indian Pharmacopoeia Commission (IPC) has waived off the Target Animal Batch Safety Test (TABST), which involved administering vaccine overdoses to animals to test each batch of vaccine for safety of a specific species starting from 1st July 2024.
Source: https://bit.ly/3WAR8U3
Source: https://bit.ly/4fgy3is

5. EU antitrust regulators have officially accepted a pharmaceutical giant’s pledge not to disparage its competitor’s iron deficiency treatment medicine.
Source: https://bit.ly/3zSqMFn

TOP 5 HEALTH LAWS AND POLICY UPDATES

The new criminal code, Bharatiya Nyaya Sanhita (BNS) has replaced the Indian Penal Code (IPC) and introduced stricter penalties for medical negligence. Registered Medical Practitioners can now face up to two years in jail and fines for medical negligence. The new law will apply from July 1, 2024.
Source: bit.ly/3RXnx5t

The Central Pollution Control Board (CPCB) has extended the last date of filing of annual returns by the registered producers, importers, brand owners (PIBOs) and plastic waste processors for FY 2022-24 and FY 2023-24 respectively till September 2024. The earlier timeline to file the annual returns were June 30, 2024 and April 30, 2024 respectively.
Source: bit.ly/3XQtxAY

In an effort to decrease reliance on imports and to promote domestic production of medical devices, the Department of Pharmaceuticals (DoP) reportedly intends to launch a new program that will provide shared facilities for medical device parks or clusters that are formed with the exclusive financial assistance of the state governments.
Source: bit.ly/3xU6b2u

The Enforcement Directorate (ED) is investigating an alleged nationwide network of contraband dealers and has placed several pharmaceutical companies under scrutiny who are engaged in the production of drugs and opioids as a measure to prevent the creation of illicit distribution networks through fraudulent sale and supply bills.
Source: bit.ly/3VNzoEw

The United States Food and Drug Administration (USFDA) has published a draft guidance that removes the requirement of undertaking switching studies for applicants undertaking an approval for treating Biosimilars as interchangeable. The USFDA has now made switching studies optional for biosimilar approvals. Hence, persons applying for approval for Biosimilars may now use computer modelling based on the current acceptable analytical technologies to demonstrate the Biosimilars as interchangeable.
Source: bit.ly/4eQUudy

TOP 5 HEALTH LAWS AND POLICY UPDATES

India’s Central Pollution Control Board has issued final warning to all Producers, Importers, Brand Owners and Plastic Waste Processors, to complete Extended Producer Responsibility (EPR) registration on dedicated EPR portal latest by June 30, 2024, or face punishment.
Source: bit.ly/4cgRsxK

India’s Health Ministry has published Guidelines for Ethical Use of Leftover De-identified/ Anonymous Samples for commercial purposes.
Source: bit.ly/3RIc0XE

The Committee on Energy and Commerce in Congress of the United States of America has sought reply from US Food and Drugs Administration (US FDA) about institutional weaknesses in US FDA’s foreign inspection program over variations in inspection outcomes from India and China.
Source: bit.ly/3RF3xEH

India’s Karnataka High Court has formed a sub-committee to draft rules for establishing Intellectual Property Division (IPD) in Karnataka High Court. IPD benches are established with specialised judges to cater to Intellectual Property Disputes.
Source: bit.ly/4bmOVR8

India’s Kerala High Court, in a recent case, has framed guidelines for prosecuting guardian of a minor, or the owner of a vehicle driven by a minor, for offences involving vehicle driven by the minor.
Source: bit.ly/3RHALDn

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

NOC for the manufacture of unapproved drugs meant for export will be issued by the Central Drug Regulator
India’s Central Drug Regulator (CDSCO) will be the competent authority to issue the No Objection Certificate (NOC) required by pharmaceutical companies for the manufacture of unapproved, new, or banned drugs for export purposes, starting from 15th May 2024. The NOC will be issued by the zonal offices of CDSCO. The application for NOC will have to be made online. Prior to CDSCO, it was the State Licensing Authorities that issued NOCs.
Source: bit.ly/4dkZO8u

Producers of Batteries can meet EPR Targets and file Annual Returns by June 30, 2024
The deadline for meeting Extended Producer Responsibility (EPR) targets and submitting annual returns by the producers of all types of batteries has been extended to June 30, 2024.
Source: bit.ly/4a0Uynx

Private hospitals demand payment of interests from the government on delay of reimbursement for treatment under Ayushman Bharat Scheme
India’s Association of Healthcare Providers (AHPI) has raised concerns over inordinate delay in receiving reimbursement for treatment provided to Ayushman Bharat beneficiaries, which impedes cash flow and poses serious operational issues for all hospitals. The Association has urged that the government pay 1 percent interest on payments delayed beyond one month under the Ayushman Bharat scheme, which is the Central Government’s flagship universal health coverage scheme, as well as change of package rate to allow beneficiaries to avail of continued benefits from the Ayushman Bharat Scheme
Source: bit.ly/3wimXHQ

US government likely to ease restrictions on regulation of Marijuana
The U.S. Drug Enforcement Administration (DEA) is likely to reclassify marijuana as a less dangerous drug by moving it from a tightly regulated class to a less tightly regulated class. Although the DEA’s proposal would highlight the medical benefits of cannabis, it would not allow its use for recreational purposes. The White House Office of Management and Budget is reportedly still in the process of reviewing the idea.
Source: bit.ly/4a2osrm

Form 483 notice need not to be responded by manufacturers of medical devices within 15 days: US Medical device experts
According to US Food and Drug Administration (FDA) officials, a medical device manufacturing company is not required to respond to a Form 483 notice (Notice of Inspectional Observations) within 15 days. The 15-day deadline for response applies to warning letters and not to Form 483 notices, though the FDA advises that if the manufacturer wishes to respond to a Form 483 notice, then it should do so within 15 days of the notice.
Source: bit.ly/44FHVxn

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Supreme Court clarifies when a patient’s negligence may be reduced due to pre-existing conditions
India’s Supreme Court has laid down the situations in which a patient’s claim for compensation due to medical negligence may be reduced on the grounds of pre-existing conditions. These are: First, when a latent condition of the patient has been unearthed; Second, when the negligence on the part of the wrongdoer re-activates a patient’s pre-existing condition that had subsided due to treatment; Third, wrongdoer’s actions aggravate known, pre-existing conditions, that have not yet received medical attention; and Fourth, when the wrongdoer’s actions accelerate an inevitable disability or loss of life due to a condition possessed by the patient even when the eventuality would have occurred with time, in the absence of the wrongdoer’s actions. This rule is commonly referred to as the ‘egg-shell skull’ rule.
Revised penalty will apply, even if the offence took place before the penalty is revised: Supreme Court
India’s Supreme Court has held that a repealed provision will cease to operate from the date of repeal and the substituted provision will commence to operate from the date of its substitution. The Court was dealing with a matter involving the determination of penalty for loss of liquor in transit. The unamended rule, which existed at the time when the breach happened, provided for a penalty of four times the duty payable on liquor.  The amended rule provided for a penalty equal to the duty payable on liquor. Since no additional guidance for the application of the amended rule was prescribed, the Supreme Court held that the amended penalty provision would apply.
Proceedings related to alcohol content in drugs under excise laws and drug laws can run concurrently: High Court
India’s Gujarat High Court has clarified that action under the Drugs & Cosmetics Act does not exempt an individual from prosecution if a case is made out under the Gujarat Prohibition Act, 1949. In this case, a pharmaceutical manufacturer had allegedly violated the State’s prohibition law by selling intoxicating substances as ayurvedic medicine and, therefore, was facing action against the excise laws as well as drug laws.
Limits on the import of Isopropyl alcohol relaxed
India’s Directorate General of Foreign Trade (DGFT) has notified the discontinuation of safeguard measures on the import of isopropyl alcohol (IPA) through a trade notice. Earlier, country-wise quantitative restrictions (QR) were imposed on the import of IPA into India.
Used imported medical devices with a minimum shelf life of 5 years are not waste: Tribunal
India’s Hyderabad Bench of Customs, Excise, and Service Tax Appellate Tribunal (CESTAT) has held that used medical devices with a minimum residual life of 5 years or more are not e-waste or hazardous waste. In this matter, a hospital had imported used medical equipment for internal use but the Customs had seized the capital equipment on grounds that the used medical equipment qualified as hazardous waste under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016